Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

The Senior Manager, Regulatory Affairs will serve as a regulatory lead to support and execute global regulatory strategies for registration and compliance of assigned products.  The individual will support program efforts relative to regulatory activities and serve as a subject matter expert to cross-functional teams.  Responsibilities may include all aspects of planning and implementation of global regulatory filings, including preparation of submissions, reviewing protocols and reports, and interpreting regulations and guidelines. 

This position will report to the Associate Director of Regulatory Affairs and will liaise closely with Regulatory Affairs and cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.

Essential Duties and Responsibilities

• Responsible for managing and supporting regulatory strategy and project workflow including prioritizing deliverables and establishing and maintaining project timelines.
• Effectively prepare regulatory submission documents in adherence with applicable regulations, directives, guidelines and/or standards.
• Facilitate product approvals and registrations through effective communications and negotiations. Lead and coordinate tracking, authoring, and review of responses to requests from health authorities.
• Manage development and negotiation of plans regarding safety, effectiveness, and quality to ensure compliance and viability for global product registrations.
• Identify risk areas and potential solutions through scenario planning and development of contingency plans.
• Collaborate closely with different functions (e.g., Program Management, Product Development, Quality, Operations, and external partners) and participate in project teams to ensure alignment of regulatory strategy and provide input on risks and benefits of potential plans.
• Support regulatory activities throughout product lifecycle and ensure registrations are maintained. Provide regulatory input, as required, in the evaluation of complaints, regulatory reporting requirements, use scenarios (RUO, IUO/PEO, IVD), quality system requirements, audits and inspections, postmarket surveillance, and other areas.
• Author, review and/or maintain procedures relating to global regulatory requirements and processes and company policies.
• Provide updates, as needed, to project teams and management regarding regulatory status and requirements of Company products.

• Advanced education degree in life sciences, engineering, law or public health with at least 6 years work-related professional experience. Or a Bachelor’s degree in similar fields with at least 8 years of experience.
• 5+ years multi/cross functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
• Knowledge of ex-US IVD or medical device development and regulatory affairs requirements
• Familiar with regulatory issues and challenges associated with diagnostic and medical device development, which may include drug/diagnostic co-development and companion diagnostics
• Solid knowledge of molecular technologies and IVD/medical device development process, including quality, compliance and life cycle management aspects
• Successful track record of supporting and maintaining product approvals and registrations through effectively preparing and coordinating global regulatory submissions
• Strong capabilities working across varied functions, cultures and backgrounds
• Innovative strategic planning and strong analytical skills
• Excellent communication skills (verbal and written) and ability to convey complex issues in a straightforward manner
• Highly organized and able to balance multiple projects effectively

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $83,440 to $128,800. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $119,200 to $161,000. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/

#LI-JL1, #LI-REGULATORYAFFAIRS, #LI-REMOTE, #LI-HIRING